BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3052679 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-03950
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 27, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SURGICALLY ABANDONED AND WILL NOT BE RETURNED FOR TESTING. THEREFORE, BOSTON SCIENTIFIC CANNOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS REMOVED FROM SERVICE DUE TO A SUSPECTED FRACTURE. NOISE WAS OBSERVED ON THE RATE SENSE PORTION OF THE LEAD WHICH WAS OVERSENSED AND RESULTED IN INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) THERAPY AND A DIVERTED SHOCK. THE NOISE COULD BE REPRODUCED WHEN THE PATIENT WAS IN A CERTAIN POSITION. THERE WERE NO OTHER INDICATIONS OF AN ISSUE WITH THIS LEAD AS OTHER MEASUREMENTS REMAINED STABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154680 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L H177| 0158| 4087| N119| 4543